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Joined: 1-May 07
|October 26, 2005|
Advocacy group issues Code Red Alert against Big Pharma bill
The National Vaccine Information Center, the country’s largest and oldest consumer-led vaccine safety organization, has issued a “Code Red Alert” against S 1873, the “Biodefense and Pandemic Vaccine and Drug Development Act of 2005” -- a newly introduced congressional bill that would allow rapid development of certain drugs and vaccines, at the same time shielding the manufacturers from liability, even if their products turn out to be lethal.
Nicknamed BioShield Two, after a related measure passed and signed into law last year [PL 108-296], S 1873 is a “drug company stockholder’s dream and a consumer’s worst nightmare,” says Barbara Loe Fisher, president of NVIC, in a hard-hitting press release. “The legislation will eliminate both regulatory and legal safeguards applied to vaccines, as well as take away the right of children and adults harmed by vaccines and drugs to present their case in front of a jury in a civil court of law.”
Sharing Fisher’s concerns, journalism professor John Hanchette, rips S 1873 in the Niagara Falls Reporter, calling the 88-page proposed measure “a legislative genuflection to Big Pharma the steamroller, powerful drug-making sector of the economy. The pharmaceutical mega-firms contribute millions to the coffers of congressional members, but if this is signed into law, they potentially could save billions."
“This bill is a slavering wolverine masquerading as a furry little lab rat,” Hanchette declares.
And that slavering wolverine is running on a fast track, its progress on the Hill fueled by media-generated hysteria about bird flu.
“The legislation is being rushed through Congress without time for voters to make their voices heard by their elected representatives,” Fisher warns.
Authored and introduced by Sen. Richard Burr, R-N.C., S 1873 sailed through the powerful Health, Education, Labor and Pensions (HELP) Committee following a voice vote on Tuesday, Oct. 18, just one day after it was introduced.
It could land on the Senate floor any time this week or next and be approved without debate or roll call. Opponents fear a similar bill is being readied on the House side, but is being kept under wraps, away from public scrutiny.
To the bill’s author and co-sponsors -- Republican Senate Majority Leader Bill Frist, R-Tenn.; Senate HELP Committee Chairman Mike Enzi, R-Wy.; and Senate Budget Committee Chairman Judd Gregg, R-N.H. -- S 1873 is all about public safety, anti-terrorism and the national defense.
“We need to improve our ability to prepare for, and respond to, bioterrorism attacks and natural outbreaks with a comprehensive approach,” said Sen. Burr, who chairs the HELP Subcommittee on Bioterrorism and Public Health Preparedness where the bill sat momentarily before being rushed to the full committee.
Burr told the committee that S 1873 “creates a true partnership” between the federal government, the pharmaceutical industry and academia to walk the drug companies “through the Valley of Death” in bringing a new vaccine to market. It will give the Department of Health and Human Services “additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines.”
Specifically, S 1873 would:
* Set up a new agency -- the Biomedical Advanced Research and Development Agency, or BARDA, to be the single point of authority within the federal government for the advanced research and development of medical countermeasures, including drugs and vaccines, in response to bioterrorism and natural disease outbreaks.
* Encourage potential researchers, manufacturers, and health care delivery partners to commit substantial resources to bring new drugs and vaccines to market more quickly.
* Provide incentive for the domestic manufacturing of medical countermeasures for pandemic and epidemic diseases.
“I believe we need to make sure someone in the Federal Government is partnering with the private sector to quickly develop drugs and vaccines should we need them,” said Burr in a press statement.
Shielding Big Pharma
The senator does not explain that Sec. 6 of the bill amends the Public Health Service Act [in Title 42 of the U.S. Code] by inserting a provision that manufacturers, distributors, and administrators of “a security countermeasure, or a qualified pandemic or epidemic product,” and health care providers using the product “shall be immune from suit or liability caused by or arising out of the design, development, clinical testing and investigation, manufacturing,” and so on, of the product.
“…No cause of action shall exist against a person described in subsection (a) for claims for loss of property, personal injury, or death arising out of, reasonably relating to, or resulting from the design, development, sale… use” … of a product “that is a designated security countermeasure or a qualified pandemic or epidemic product by the Secretary [of HHS] in a declaration …”
Nor does Burr’s statement let the public know that BARDA, the new agency, its working groups and advisory boards will be allowed to operate in secret, exempt from provisions of the Freedom of Information Act and the Federal Advisory Committee Act [PL 92-463; 5 US Code].
FACA, a law not as well known as FOIA, provides that a person “suffering a legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute is entitled to judicial review thereof.”
In an interview with NewsWithViews, Fisher spelled out what all this means for someone who might be affected by one of the drugs or vaccines produced by a “partnering” company, which a person could be forced to take if the secretary of Health and Human Services declares a bio-threat or other medical emergency.
Denial of justice
“Not only can’t you get at them [a drug manufacturer] because it wipes out the ability to go court, to have your day in court, but it also shields them from the light to find out exactly what is happening with adverse events because [with] this BARDA that they’re setting up, the information will all be protected,” she said. “If people are dying and having seizures after being vaccinated or using these drugs, you will never be able to get a handle on what is actually happening because it’s all protected. You can’t use FOIA, you can’t go to court, you can’t do anything.”
Fisher observed that one of the features of any lawsuit is the process of discovery, which allows lawyers, the plaintiff and defendant to go into the archives and files of the various parties (such as drug companies) to get information necessary to put a case together. By closing off access to the courts otherwise allowed by the Federal Advisory Committee Act and the Public Health Service Act, and effectively shutting the door on FOIA and the discovery process a huge shield is created for the drug companies.
“If they cut off the pass in terms of judicial review and they cut off the pass in terms of FOIA, you’ll have no ability to get a handle on what’s happening,” Fisher said.
There are other concerns. Opponents of this and earlier measures have focused on the possibility of forced vaccination and drugging.
There’s nothing about either forced drugging or forced vaccination programs in S 1873, which deals with matters of liability, not enforcement. But the danger of such programs is nonetheless very real and would be heightened if the bill is passed.
As Fisher sees it, S 1873 is one part of a bigger picture and must be taken in context with other legislation already on the books that this measure builds on namely, the Homeland Security Act, the BioShield Act of 2004, and the Model States Health Emergency Powers Act, which is being enacted at the state level.
“Those define what the secretary of Health and Human Services can do when he or she declares a public health emergency,” she said. “This piece of legislation, the Burr bill, completes the circle in that it lets everyone off the hook in terms of liability. It completes the concentration of power in the hands of the secretary of Health and Human Services who is an appointee of the Administration, just like the Homeland Security Act [of 2002, PL 107-296] tipped the balance of power in favor of the Executive Branch.
“Where the authors of the Constitution tried to achieve a balance between the judiciary, the legislative, and the executive branches we now have a concentration of power in the Executive Branch. These pieces of legislation taken together do not allow any oversight on what the Executive Branch is doing in the areas of declaring an actual public health emergency or an imminent or potential public health emergency and then setting into motion forced quarantine, forced vaccination and drug taking. There’s total immunity from liability (even in case sickness or death occurs) for anyone who is involved in that process, and there’s no judicial review.
“So it’s a tremendous amount of power concentrated in the hands of the Secretary of Health and Human Service.”
And this power, granted under last year’s BioShield Act, has already been exercised. As an example Fisher cited a recent case in Washington, D.C., in which federal court judge Emmett Sullivan, a Clinton appointee, declared the anthrax vaccine program to be illegal and issued an injunction against further mandatory use of the vaccine. He ruled that despite assertions by the Dept. of Defense and the FDA, the vaccine was “investigational” and “unapproved for its intended use,” and therefore could not be given to members of the armed services without informing them of the safety risks.
That was in October 2004, shortly after the passage of the BioShield Act which President Bush called for in his 2003 State of the Union address.
Fisher continued: “When he [Sullivan] did that, the secretary of HHS with the secretary of Defense issued an Emergency Use Authorization declaring an emergency. Under the law they did not have to tell anyone what that emergency is, the nature of the emergency. It is not reviewable. They issued this Emergency Use Authorization thereby circumventing the court’s injunction.”
Sullivan later agreed that the feds had the power under the BioShield Act and lifted the injunction, but said the personnel would have to be informed of the benefits and risks of the vaccine, and it would have to be made clear to them that the program was voluntary and they were not being forced.
But, Fisher points out, “This is a career killer. If you don’t get the shots, they can say you endanger yourself and the troops that you’re with.”
“So we know that once they’ve exercised the Emergency Use Authorization under Project BioShield in a military setting, they have the ability to do it in the civilian setting because this federal legislation -- S 1873 sets it up for them in either setting,” Fisher said.
National Vaccine Information Centerhttp://www.nvic.org/This website says this Bill did not pass, However another one did pass:http://www.govtrack.us/congress/bill.xpd?bill=s109-1873Similar Bills to the one above:http://www.govtrack.us/congress/bill.xpd?b...873&tab=related